Class: Expectorants
VA Class: RE516
CAS Number: 93-14-1
Brands: Broncholate, Bronkaid, Brontex, Cheracol Syrup, Congestac, D-Feda II, Diabetic Tussin EX, Donatussin Pediatric, Dyflex-G, Dy-G, Dyphylline GG, Ganidin NR, Gani-Tuss NR, Guiatuss, Guiatuss AC, Hytuss, Hytuss-2X, Lufyllin-GG, Mucinex, Mucinex D, Organidin NR, Phanasin Diabetic Choice, Primatene, Pseudovent 400, Rescon GG, Robitussin, Sine-Off, Sinutab Non-Drying, Sudafed PE Non-Drying Sinus, Touro LA Caplets, Triaminic Chest and Nasal Congestion, Tussi-Organidin NR, Tussi-Organidin-S NR
Introduction
Expectorant.a
Uses for Guaifenesin
Cough
Symptomatic management of productive cough to loosen and thin sputum and bronchial secretions and ease expectoration.a
Improves cough symptoms associated with common cold, bronchitis, laryngitis, pharyngitis, pertussis, influenza, measles, and coughs provoked by chronic paranasal sinusitis.a
May be useful in the management of irritative nonproductive cough and coughs productive of scanty amounts of thick, viscous secretions.a
May indirectly diminish the tendency to cough, but mechanism of this effect differs from that of antitussives (which inhibit or suppress cough); insufficient evidence to support efficacy as antitussive.a
Used in fixed combination with other agents (e.g., acetaminophen, chlorpheniramine, dextromethorphan, ephedrine, phenylephrine, pseudoephedrine) for the temporary relief of productive cough and/or other symptoms (nasal congestion, fever).e f g h i j
Guaifenesin Dosage and Administration
Administration
Administer orally.a
Do not break, crush, or chew extended-release tablets.a
Dosage
Because combinations and dosage strengths vary for fixed-combination preparations, consult manufacturer's product labeling for appropriate dosage of the specific preparation.
Pediatric Patients
Cough
Oral
Children <2 years of age: Individualize dosage.a (See Pediatric Use under Cautions.)
Children 2 to <6 years of age, conventional preparations: 50–100 mg every 4 hours, up to 600 mg daily.a (See Pediatric Use under Cautions.)
Children 2–6 years of age, extended-release preparations: 300 mg every 12 hours, up to 600 mg daily.a (See Pediatric Use under Cautions.)
Children 6 to <12 years of age, conventional preparations: 100–200 mg every 4 hours, up to 1.2 g daily.a
Children 6–12 years of age, extended-release preparations: 600 mg every 12 hours, up to 1.2 g daily.a
Children ≥12 years of age, conventional preparations: 200–400 mg every 4 hours, up to 2.4 g daily.a
Children ≥12 years of age, 600-mg extended-release tablets: 600 mg or 1.2 g every 12 hours, up to 2.4 g daily.a
Adults
Cough
Oral
Conventional preparations: 200–400 mg every 4 hours, up to 2.4 g daily.a
600-mg extended-release tablets: 600 mg or 1.2 g every 12 hours, up to 2.4 g daily.a
Prescribing Limits
Pediatric Patients
Cough
Oral
Children 2 to <6 years of age, conventional preparations: Maximum 600 mg daily.a
Children 2–6 years of age, extended-release preparations: Maximum 600 mg daily.a
Children 6 to <12 years of age, conventional preparations: Maximum 1.2 g daily.a
Children 6–12 years of age, extended-release preparations: Maximum 1.2 g daily.a
Children ≥12 years of age, conventional preparations: Maximum 2.4 g daily.a
Children ≥12 years of age, extended-release preparations: Maximum 2.4 g daily.a
Adults
Cough
Oral
Conventional preparations: Maximum 2.4 g daily.a
Extended-release preparations: Maximum 2.4 g daily.a
Cautions for Guaifenesin
Contraindications
Known hypersensitivity to guaifenesin.
Warnings/Precautions
General Precautions
Excessive Dosage
Emesis may result from doses larger than those required for expectorant action, but GI upset at ordinary dosage is rare.a
Persistent Cough
Do not use as self-medication for persistent or chronic cough (e.g., that associated with smoking, asthma, chronic bronchitis, emphysema), or cough accompanied by excessive phlegm unless directed by a clinician.a
Persistent cough may indicate serious condition; if it persists for >1 week, is recurrent, or is accompanied by fever, rash, or persistent headache, consult a clinician.a
Use of Fixed Combinations
When used in fixed combination with other agents (e.g., acetaminophen, chlorpheniramine, dextromethorphan, ephedrine, phenylephrine, pseudoephedrine), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).e f g h i j
Specific Populations
Pregnancy
Category C.b
Lactation
Not known whether guaifenesin is distributed into milk.b
Pediatric Use
Safety and efficacy of Mucinex 600-mg extended-release tablets not established in children <12 years of age.a
Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.c d Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.c Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.
Stability
Storage
Tight containers.a
ActionsActions
Reduces the viscosity of tenacious secretions and acts as an expectorant by increasing respiratory tract fluid.a
Increases expectorated sputum volume over the first 4–6 days of a productive cough, decreases sputum viscosity and difficulty in expectoration, and improves associated symptoms.a
Advice to Patients
Importance of contacting a clinician if cough persists for >1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.a
Importance of not using for self-medication for persistent or chronic cough unless directed by a clinician.a
Importance of keeping Mucinex 600-mg extended-release tablets out of reach of young children to avoid accidental swallowing and choking.a
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 200 mg | Hytuss-2X | Hyrex |
Solution | 100 mg/5 mL* | Phanasin Diabetic Choice (with parabens and propylene glycol) | Pharmakon | |
Diabetic Tussin EX (with aspartame and methylparaben) | Health Care Products | |||
Ganidin NR | Cypress | |||
Guiatuss Syrup | Alpharma, Teva | |||
Mucinex (with parabens and propylene glycol) | Adams | |||
Robitussin Chest Congestion (with propylene glycol) | Wyeth | |||
Tablets | 100 mg | Hytuss (scored) | Hyrex | |
200 mg | Organidin NR (scored) | MEDA | ||
Tablets, extended-release | 600 mg | Mucinex | Adams |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Solution | 33.3 mg/5 mL with Dyphylline 33.3 mg/5 mL | Dyphylline GG Elixir (with alcohol 17%) | Cypress |
Lufyllin-GG Elixir (with alcohol 17%) | MEDA | |||
100 mg/5 mL with Dyphylline 100 mg/5 mL | Dy-G | Cypress | ||
Tablets | 200 mg with Dyphylline 200 mg | Dyflex-G | EconoMed | |
Dyphylline GG (scored) | Breckenridge | |||
Lufyllin-GG (scored) | MEDA |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Solution | 75 mg/5 mL with Codeine Phosphate 2.5 mg/5 mL | Brontex (C-V; with methylparaben) | Kenwood |
100 mg/5 mL with Codeine Phosphate 10 mg/5 mL* | Cheracol Syrup (C-V; with alcohol 4.75%) | Lee | ||
Gani-Tuss NR (C-V) | Cypress | |||
Guiatuss AC Syrup (C-V; with alcohol 3.5%) | Alpharma | |||
Tussi-Organidin NR (C-V; with povidone and propylene glycol) | Victory Pharma | |||
Tussi-Organidin-S NR (C-V; with povidone and propylene glycol and with graduated oral syringe) | Victory Pharma | |||
Tablets | 300 mg with Codeine Phosphate 10 mg | Brontex (C-III) | Kenwood |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules, extended-release | 400 mg with Pseudoephedrine Hydrochloride 120 mg | Pseudovent 400 (with propylene glycol) | Ethex |
Solution | 50 mg/5 mL with Phenylephrine Hydrochloride 2.5 mg/5 mL | Triaminic Chest and Nasal Congestion (with propylene glycol) | Novartis | |
100 mg/5 mL with Ephedrine Hydrochloride 6.25 mg/5 mL | Broncholate Syrup | Sanofi-Aventis | ||
100 mg/5 mL with Phenylephrine Hydrochloride 5 mg/5 mL | Rescon GG (with parabens and propylene glycol) | Capellon | ||
Robitussin Head and Chest Congestion PE (with propylene glycol) | Wyeth | |||
20 mg/mL with Phenylephrine Hydrochloride 1.5 mg/mL | Donatussin Pediatric Drops (with propylene glycol) | Laser | ||
Tablets | 200 mg with Ephedrine Hydrochloride 12.5 mg | Primatene (with povidone) | Wyeth | |
200 mg with Phenylephrine Hydrochloride 5 mg | Sinutab Non-Drying Caplets | Pfizer | ||
Sudafed PE Non-Drying Sinus Caplets | Pfizer | |||
400 mg with Ephedrine Sulfate 25 mg | Bronkaid Dual Action Caplets (with polyethylene glycol and povidone) | Bayer | ||
400 mg with Pseudoephedrine Hydrochloride 60 mg | Congestac Caplets (with polyethylene glycol and povidone) | BF Ascher | ||
Tablets, extended-release | 500 mg with Pseudoephedrine Hydrochloride 120 mg | Touro LA LA Caplets (scored) | Dartmouth | |
600 mg with Pseudoephedrine Hydrochloride 60 mg | D-Feda II | WE Pharmaceuticals | ||
Mucinex D | Adams |
Guaifenesin also is commercially available in combination with antihistamines, antitussives, bronchodilators, decongestants, and expectorants.
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Bidex-DM 30-800MG 12-hr Tablets (STEWART JACKSON): 30/$29.99 or 90/$81.97
Cheratussin AC 100-10MG/5ML Syrup (QUALITEST): 118/$11.99 or 354/$19.97
Cheratussin AC 100-10MG/5ML Syrup (QUALITEST): 480/$15.99 or 1440/$25.97
Cheratussin DAC 30-10-100MG/5ML Solution (QUALITEST): 480/$35.99 or 960/$60.97
Donatussin 10-2-15-100MG/5ML Syrup (LASER PHARMACEUTICALS): 473/$36.25 or 1419/$108.75
Duraphen Forte 30-30-1200MG 12-hr Tablets (KOWA PHARMACEUTICALS AMERICA): 100/$135.98 or 300/$375.97
GFN 1200/DM 60 1200-60MG 12-hr Tablets (CYPRESS PHARMACEUTICAL): 30/$24.99 or 90/$65.97
Guaifenesin-DM 100-10MG/5ML Liquid (MORTON GROVE PHARMACEUTICALS): 240/$18.99 or 720/$49.97
Guiatuss 100MG/5ML Syrup (IVAX PHARMACEUTICALS INC.): 473/$14.99 or 946/$18.97
Medent LD 60-800MG 12-hr Tablets (STEWART JACKSON): 30/$28.99 or 90/$72.97
Mucinex 600MG 12-hr Tablets (RECKITT BENCKISER): 20/$19.99 or 40/$28.97
Mytussin DAC 30-10-100MG/5ML Solution (MORTON GROVE PHARMACEUTICALS): 473/$39.66 or 1419/$118.98
Naldecon Senior EX 200MG/5ML Syrup (APOTHECON): 118/$15.99 or 236/$22.98
Organidin NR 100MG/5ML Liquid (MEDA PHARMACEUTICALS): 120/$55.99 or 360/$159.97
Organidin NR 200MG Tablets (MEDA PHARMACEUTICALS): 30/$29.99 or 90/$82.97
Sitrex 30-1200MG 12-hr Tablets (VINDEX PHARMACEUTICALS INC.): 30/$26.99 or 90/$59.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
a. AHFS drug information 2004. McEvoy GK, ed. Guaifenesin. Bethesda, MD: American Society of Health-System Pharmacists; 2004: 2605-7.
b. Briggs GG, Freeman RK, Yaffee SJ. Drugs in pregnancy and lactation. 6th ed. Philadelphia, PA: Lippincott Williams &Wilkins; 2002: 636-7/g.
c. Srinivasan A, Budnitz D, Shehab N et al. Infant deaths associated with cough and cold medications—two states, 2005. MMWR Morb Mortal Wkly Rep. 2007; 56:1-4. [PubMed 17218934]
d. Food and Drug Administration. Cough and cold medications in children less than two years of age. Rockville, MD; 2007 Jan 12. From FDA website ().
e. Ethex Corporation. Pseudovent 400 (pseudoephedrine hydrochloride and guaifenesin) extended-release capsules prescribing information. St. Louis, MO; 2004 Aug.
f. Novartis Consumer Health, Inc. Triaminic Chest & Nasal Congestion (guaifenesin and phenylephrine hydrochloride) oral solution patient information. From Novartis Consumer Health website (). Accessed 2008 Feb 26.
g. Hogil Pharmaceutical Corp. Sine-Off Severe Cold (acetaminophen, guaifenesin, and phenylephrine hydrochloride) caplets patient information. From Hogil website (). Accessed 2008 Feb 27.
h. Wyeth Consumer Healthcare. Primatene (ephedrine hydrochloride and guaifenesin) tablets patient information. From Wyeth Consumer Healthcare website (). Accessed 2008 Feb 26.
i. Wyeth Consumer Healthcare. Robitussin Cough & Cold CF (dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride) syrup patient information. From Wyeth Consumer Healthcare website (). Accessed 2008 Feb 26.
j. Cypress Pharmaceutical Inc. ChlorDex GP (dextromethorphan hydrobromide, chlorpheniramine maleate, phenylephrine hydrochloride, and guaifenesin) syrup prescribing information. Madison, MS; 2006 Oct.
More Guaifenesin resources
- Guaifenesin Side Effects (in more detail)
- Guaifenesin Use in Pregnancy & Breastfeeding
- Drug Images
- Guaifenesin Support Group
- 51 Reviews for Guaifenesin - Add your own review/rating
- Guaifenesin Granules MedFacts Consumer Leaflet (Wolters Kluwer)
- Allfen MedFacts Consumer Leaflet (Wolters Kluwer)
- Guaifenesin NR Prescribing Information (FDA)
- Hytuss Immediate-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)
- Mucinex Consumer Overview
- Mucinex Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Mucinex Prescribing Information (FDA)
- Organidin NR Prescribing Information (FDA)
- Tussin Consumer Overview
- guaifenesin Advanced Consumer (Micromedex) - Includes Dosage Information
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